As
filed with the Securities and Exchange Commission on June 17, 2024
Registration
No. 333-280134
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Amendment
No. 1 to
Form
S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
ABEONA
THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
| Delaware |
|
83-0221517 |
| (State
or other jurisdiction |
|
(I.R.S.
Employer |
| of
incorporation or organization) |
|
Identification
No.) |
6555 Carnegie Avenue, 4th Floor
Cleveland, OH 44103
(646) 813-4701
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
Sean
M. Ewen, Esq.
Jared N. Fertman, Esq.
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York, NY 10019-6099
(212) 728-8000
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
Approximate
date of commencement of proposed sale to the public: From time to time after the registration statement becomes effective.
If
the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check
the following box. ☐
If
any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following
box. ☒
If
this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same
offering. ☐
If
this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If
this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective
upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large
accelerated filer ☐ |
Accelerated
filer ☐ |
| Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
| |
Emerging
growth company ☐ |
If
an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act. ☐
We
hereby amend this registration statement (the “Registration Statement”) on such date or dates as may be necessary to delay
its effective date until we shall file a further amendment which specifically states that this Registration Statement shall thereafter
become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective
on such date as the Commission, acting pursuant to said Section 8(a), may determine.
Explanatory
Note
This
registration statement contains two prospectuses:
| ● | a
base prospectus covering the offering, issuance and sale of such indeterminate number of
shares of common stock and preferred stock, such indeterminate number of warrants to purchase
common stock and preferred stock and such indeterminate number of units as shall have an
aggregate initial offering price not to exceed $300,000,000; and |
| | | |
| ● | an
at-the-market offering prospectus covering the offering, issuance and sale of shares of our
common stock with an aggregate offering price of up to $75,000,000 that may be issued and
sold under our outstanding Open Market Sale Agreement entered into with Jefferies LLC on
August 17, 2018, as amended on November 19, 2021. |
The
base prospectus immediately follows this explanatory note. The specific terms of any securities to be offered pursuant to the base prospectus
will be specified in a prospectus supplement to the base prospectus. The at-the-market offering prospectus immediately follows the base
prospectus. The common stock that may be offered, issued and sold under the at-the-market offering prospectus is included in the $300,000,000
of securities that may be offered, issued and sold by us under the base prospectus.
Upon
termination of the sales agreement with Jefferies LLC, any portion of the $75,000,000 included in the at-the-market offering prospectus
that is not sold pursuant to the sales agreement will be available for sale in other offerings pursuant to the base prospectus and a
corresponding prospectus supplement.
THE
INFORMATION IN THIS PROSPECTUS MAY CHANGE OR BE AMENDED. WE MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IS NOT SOLICITING AN
OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT
TO COMPLETION, DATED JUNE 17, 2024
PROSPECTUS
$300,000,000
Common
Stock
Preferred
Stock
Warrants
Debt
Securities
This
prospectus will allow us to issue, from time to time at prices and on terms to be determined at or prior to the time of the offering,
up to $300,000,000 of any combination of the securities described in this prospectus, including common stock, preferred stock, warrants
and/or debt securities. We may also offer common stock or preferred stock upon conversion of or exchange for the debt securities
or common stock, preferred stock or debt securities upon the exercise of warrants.
This
prospectus describes the general terms of these securities and the general manner in which these securities will be offered. We will
provide you with the specific terms of any offering in one or more supplements to this prospectus. We may also authorize one or more
free writing prospectuses to be provided to you in connection with these offerings. The prospectus supplements and any related free writing
prospectus will also describe the specific manner in which these securities will be offered and may also supplement, update or amend
information contained in this document. You should read this prospectus, any prospectus supplement, and any related free writing prospectus,
as well as any documents incorporated by reference into this prospectus or any prospectus supplement, carefully before you invest.
Our
securities may be sold directly by us to you, through agents designated from time to time or to or through underwriters or dealers. For
additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution” in this prospectus
and in the applicable prospectus supplement. If any underwriters or agents are involved in the sale of our securities with respect to
which this prospectus is being delivered, the names of such underwriters or agents and any applicable fees, commissions or discounts
and over-allotment options will be set forth in a prospectus supplement. The price to the public of such securities and the net proceeds
that we expect to receive from such sale will also be set forth in a prospectus supplement.
Our
common stock is listed on The Nasdaq Capital Market (“Nasdaq”), under the symbol “ABEO.” On June 10, 2024, the
last reported sale price of our common stock on Nasdaq was $4.46 per share.
Investing
in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully
the risks that we have described on page 4 of this prospectus under the caption “Risk Factors.” We may include specific
risk factors in supplements to this prospectus and any related free writing prospectus under the caption “Risk Factors.”
This prospectus may not be used to sell our securities unless accompanied by a prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is June , 2024.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a “shelf” registration statement. Under this shelf registration process, we may sell, at any time and
from time to time, in one or more offerings, any combination of the securities described in this prospectus. The exhibits to our Registration
Statement contain the full text of certain contracts and other important documents we have summarized in this prospectus. Since these
summaries may not contain all the information that you may find important in deciding whether to purchase the securities we offer, you
should review the full text of these documents. The Registration Statement and the exhibits can be obtained from the Securities and Exchange
Commission (“SEC”) as indicated under the heading “Where You Can Find More Information; Incorporation By Reference.”
This
prospectus only provides you with a general description of the securities we may offer. Each time we sell securities, we will provide
a prospectus supplement that contains specific information about the terms of those securities and the terms of that offering. The prospectus
supplement may also add, update, or change information contained in this prospectus. You should read both this prospectus and any prospectus
supplement together with the additional information described below under the heading “Where You Can Find More Information; Incorporation
By Reference.”
We
have not authorized any dealer, agent, or other person to give any information or to make any representation other than those contained
or incorporated by reference into this prospectus and any accompanying prospectus supplement. You must not rely upon any information
or representation not contained or incorporated by reference into this prospectus or an accompanying prospectus supplement. This prospectus
and the accompanying prospectus supplement, if any, do not constitute an offer to sell or the solicitation of an offer to buy any securities
other than the registered securities to which they relate, nor do this prospectus and the accompanying prospectus supplement, if any,
constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction to any person to whom it is unlawful
to make such offer or solicitation in such jurisdiction. You should not assume that the information contained in this prospectus and
any accompanying prospectus supplement is accurate on any date subsequent to the date set forth on the front of the document or that
any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference,
even though this prospectus and any accompanying prospectus supplement is delivered or securities are sold on a later date.
References
in this prospectus to the terms “the Company,” “Abeona,” “we,” “our” and “us”
or other similar terms mean Abeona Therapeutics Inc., unless we state otherwise or the context indicates otherwise.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus, any prospectus supplement, and the other documents we have filed with the SEC that are incorporated herein by reference contain
forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts,
regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives
of management or other financial items are forward-looking statements. The words “anticipate,” “believe,” “estimate,”
“expect,” “seek,” “intend,” “may,” “plan,” “predict,” “project,”
“will,” “would” and similar expressions are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
We
may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this
prospectus, particularly as set forth and incorporated by reference into the “Risk Factors” section below, that we believe
could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements
do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations, or investments
we may make.
You
should read this prospectus, any supplements to this prospectus and the documents that we incorporate by reference into this prospectus
completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume
any obligation to update any forward-looking statements, except as otherwise required by law. We advise you, however, to consult any
further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current
reports on Form 8-K we file with or furnish to the SEC.
THE
COMPANY
Overview
We
are a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. Our lead clinical program
is pz-cel, investigational autologous, COL7A1 gene-corrected epidermal sheets, currently in development for recessive dystrophic epidermolysis
bullosa (“RDEB”). We have announced positive data from our VIITAL™ Phase 3 study evaluating the efficacy, safety and
tolerability of pz-cel. The VIITAL™ study met its two co-primary efficacy endpoints demonstrating statistically significant, clinically
meaningful improvements in wound healing and pain reduction in large chronic RDEB wounds. On September 25, 2023, we submitted a Biologics
License Application (“BLA”) for pz-cel to the U.S. Food and Drug Administration (“FDA”).
In
November 2023, the FDA accepted and granted priority review for our BLA for pz-cel, and subsequently, under the Prescription Drug User
Fee Act (“PDUFA”), the FDA set a target action date of May 25, 2024. However, in April 2024, the FDA issued a Complete Response
Letter (“CRL”) in response to the BLA. The CRL follows the completion of Abeona’s Late Cycle Review Meeting with the
FDA in March 2024. At the Late Cycle Review Meeting and in a subsequent information request, the FDA noted that certain additional information
needed to satisfy Chemistry Manufacturing and Controls (“CMC”) requirements must be satisfactorily resolved before the application
can be approved. In response, we submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval, and full validation
reports after approval in mid-2024. In addition, we discussed these plans with the FDA in a subsequent informal meeting. In the CRL,
the FDA indicated that the proposed timing of the data submission by us would not allow sufficient time for the FDA to complete its review
by the May 25, 2024 PDUFA date.
The
information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing
methods, including some that were captured in the observations during the FDA’s pre-license inspection (“PLI”). The
CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request
any new clinical trials or clinical data to support the approval of pz-cel. We anticipate completing and submitting the requested CMC
information in the second half of 2024.
We
have continued to prepare our current Good Manufacturing Practices (“cGMP”) commercial facility in Cleveland, Ohio for manufacturing
pz-cel drug product to support our planned commercial launch of pz-cel, if approved. Pz-cel study drug product for all our VIITAL™
study participants has been manufactured at our Cleveland facility. As part of our commercial planning, we continue to engage with stakeholders
across the healthcare system, including public and private payors, and healthcare providers to better understand market access and potential
pricing for pz-cel. We have also begun discussions with high volume treatment centers of excellence to onboard them for pz-cel application
upon potential FDA approval.
Our
development portfolio also features adeno-associated virus (“AAV”) based gene therapies designed to treat ophthalmic diseases
using the novel AIM™ capsid platform that we have exclusively licensed from the University of North Carolina at Chapel Hill, and
internal AAV vector research programs.
Preclinical
Pipeline
Our
preclinical programs are investigating the use of novel AAV capsids in AAV-based therapies for serious genetic eye diseases, including
ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (“XLRS”) and ABO-505 for autosomal dominant optic atrophy
(“ADOA”). We have completed pre-Investigational New Drug Application meetings with the FDA regarding our preclinical development
plans and regulatory requirements to support first-in-human trials.
Company
Information
We
were incorporated in 1974. On October 24, 2014, we changed our name to PlasmaTech Biopharmaceuticals, Inc., and on June 19, 2015, we
changed our name to Abeona Therapeutics Inc. to reflect our broader rare disease commitment. Our principal executive office is located
at 6555 Carnegie Avenue, 4th Floor, Cleveland, Ohio 44103, and our telephone number is (646) 813-4701. Our website address
is www.abeonatherapeutics.com. We do not incorporate by reference into this prospectus the information on our website, and you should
not consider it as part of this prospectus.
Risk
Factors
An
investment in our securities involves risks and uncertainties. Before making an investment decision, you should carefully consider these
risks as well as other information we include or incorporate by reference in this prospectus. In particular, you should carefully consider
the information under the heading “Risk Factors,” as well as the factors listed under the heading ” Forward-Looking
Statements,” in each case contained in our Annual Report on Form 10-K for our most recent fiscal year, in any Quarterly Reports
on Form 10-Q that have been filed since our most recent Annual Report on Form 10-K, and in any other documents that we file (not furnish)
with the SEC under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), each of which is incorporated by
reference in this prospectus. Any of the risks described could significantly and negatively affect our business, financial condition,
results of operations, cash flows and prospects and the trading price of our securities. You could lose all or part of your investment.
Use
Of Proceeds
We
intend to use the net proceeds from this offering primarily to fund preparations for resubmission of our BLA and for commercialization
of our product candidate pz-cel, as well as for working capital and general corporate purposes. The amounts and timing of our use of
the net proceeds from the sale of securities in this offering will depend on a number of factors, such as regulatory approvals, commercial
infrastructure expansion, the timing and progress of our pre-clinical product candidates and our development efforts, technological advances
and the competitive environment for our product candidates.
As
of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering.
Accordingly, our management will have broad discretion in the timing and application of these proceeds. Pending application of the net
proceeds as described above, we may invest the net proceeds of this offering in a variety of capital preservation investments, including
but not limited to short-term, interest-bearing investment grade government securities, money market accounts, certificates of deposit
and direct or guaranteed obligations of the U.S. government.
Plan
of distribution
We
may sell the offered securities in any of the ways described below or in any combination or any other way set forth in an applicable
prospectus supplement from time to time:
| ● | to
or through underwriters or dealers; |
| | | |
| ● | through
one or more agents; or |
| | | |
| ● | directly
to purchasers or to a single purchaser. |
The
distribution of the securities may be effected from time to time in one or more transactions:
| ● | at
a fixed price, or prices, which may be changed from time to time; |
| | | |
| ● | at
market prices prevailing at the time of sale; |
| | | |
| ● | at
prices related to such prevailing market prices; or |
| | | |
| ● | at
negotiated prices. |
Each
prospectus supplement will describe the method of distribution of the securities and any applicable restrictions.
The
prospectus supplement with respect to the securities of a particular series will describe the terms of the offering of the securities,
including the following:
| ● | the
name or names of any underwriters, dealers or agents and the amounts of securities underwritten
or purchased by each of them; |
| | | |
| ● | the
public offering price of the securities and the proceeds to us and any discounts, commissions
or concessions allowed or reallowed or paid to dealers; and |
| | | |
| ● | any
securities exchanges on which the securities may be listed. |
Any
offering price and any discounts or concessions allowed or reallowed or paid to dealers may be changed from time to time.
Only
the agents or underwriters named in each prospectus supplement are agents or underwriters in connection with the securities being offered
thereby.
We
may authorize underwriters, dealers or other persons acting as our agents to solicit offers by certain institutions to purchase securities
from us pursuant to delayed delivery contracts providing for payment and delivery on the date stated in each applicable prospectus supplement.
Each contract will be for an amount not less than, and the aggregate amount of securities sold pursuant to such contracts shall not be
less nor more than, the respective amounts stated in each applicable prospectus supplement. Institutions with whom the contracts, when
authorized, may be made include commercial and savings banks, insurance companies, pension funds, investment companies, educational and
charitable institutions, and other institutions, but shall in all cases be subject to our approval. Delayed delivery contracts will be
subject only to those conditions set forth in each applicable prospectus supplement, and each prospectus supplement will set forth any
commissions we pay for solicitation of these contracts.
Agents,
underwriters and other third parties described above may be entitled to indemnification by us against certain civil liabilities, including
liabilities under the Securities Act of 1933, as amended (the “Securities Act”), or to contribution from us with respect
to payments which the agents, underwriters or other third parties may be required to make in respect thereof. Agents, underwriters and
such other third parties may be customers of, engage in transactions with, or perform services for us in the ordinary course of business.
One
or more firms, referred to as “remarketing firms,” may also offer or sell the securities, if a prospectus supplement so indicates,
in connection with a remarketing arrangement upon their purchase. Remarketing firms will act as principals for their own accounts or
as our agents. These remarketing firms will offer or sell the securities in accordance with the terms of the securities. Each prospectus
supplement will identify and describe any remarketing firm and the terms of its agreement, if any, with us and will describe the remarketing
firm’s compensation. Remarketing firms may be deemed to be underwriters in connection with the securities they remarket. Remarketing
firms may be entitled under agreements that may be entered into with us to indemnification by us against certain civil liabilities, including
liabilities under the Securities Act, and may be customers of, engage in transactions with or perform services for us in the ordinary
course of business.
Certain
underwriters may use this prospectus and any accompanying prospectus supplement for offers and sales related to market-making transactions
in the securities. These underwriters may act as principal or agent in these transactions, and the sales will be made at prices related
to prevailing market prices at the time of sale.
The
securities we offer may be new issues of securities and may have no established trading market. The securities may or may not be listed
on a securities exchange. Underwriters may make a market in these securities, but will not be obligated to do so and may discontinue
any market making at any time without notice. We can make no assurance as to the liquidity of, or the existence of trading markets for,
any of the securities.
Certain
persons participating in an offering may engage in overallotment, stabilizing transactions, short covering transactions and penalty bids
in accordance with rules and regulations under the Exchange Act. Overallotment involves sales in excess of the offering size, which create
a short position. Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed
a specified maximum. Short covering transactions involve purchases of the securities in the open market after the distribution is completed
to cover short positions. Penalty bids permit the underwriters to reclaim a selling concession from a dealer when the securities originally
sold by the dealer are purchased in a short covering transaction to cover short positions. Those activities may cause the price of the
securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time.
We
also may sell any of the securities through agents designated by us from time to time. We will name any agent involved in the offer or
sale of these securities and will list commissions payable by us to these agents in the applicable prospectus supplement. These agents
will be acting on a best efforts basis to solicit purchases for the period of its appointment, unless stated otherwise in the applicable
prospectuses.
We
may sell any of the securities directly to purchasers. In this case, we will not engage underwriters or agents in the offer and sale
of these securities.
We
may engage in sales deemed to be “at the market offerings” as defined in Rule 415 promulgated under the Securities Act, including
sales made directly on or through Nasdaq, the existing trading market for our common stock, sales made to or through a market maker other
than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to
such prevailing market prices and/or any other method permitted by law. The terms of such “at the market offerings” will
be set forth in the applicable prospectus supplement. We may engage an agent to act as a sales agent in such “at the market offerings”
on a best efforts basis using commercially reasonable efforts consistent with normal trading and sales practices, on mutually agreed
terms between such agent and us. We will name any agent involved in such “at the market offerings” of securities and will
list commissions payable by us to these agents in the applicable prospectus supplement.
In
addition, we may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties
in privately negotiated transactions. If the applicable prospectus supplement so indicates, in connection with those derivatives, the
third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short sale transactions.
If so, the third party may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related
open borrowings of stock, and may use securities received from us in settlement of those derivatives to close out any related open borrowings
of stock. The third party in such sale transactions will be an underwriter and, if not identified in this prospectus, will be named in
the applicable prospectus supplement (or a post-effective amendment). In addition, we may otherwise loan or pledge securities to a financial
institution or other third party that in turn may sell the securities short using this prospectus and an applicable prospectus supplement.
Such financial institution or other third party may transfer its economic short position to investors in our securities or in connection
with a concurrent offering of other securities.
The
specific terms of any lock-up provisions in respect of any given offering will be described in the applicable prospectus supplement.
In
compliance with the guidelines of the Financial Industry Regulatory Authority, Inc. (“FINRA”), the maximum consideration
or discount to be received by any FINRA member or independent broker dealer may not exceed 8% of the aggregate proceeds of the offering.
The
underwriters, dealers and agents may engage in transactions with us, or perform services for us, in the ordinary course of business for
which they receive compensation.
GENERAL
DESCRIPTION OF SECURITIES THAT WE MAY SELL
We
may offer and sell, at any time and from time to time:
| ● | Shares
of our common stock; |
| | | |
| ● | Shares
of our preferred stock; |
| | | |
| ● | Warrants
to purchase shares of our common stock, preferred stock and/or debt securities; |
| | | |
| ● | Debt
securities consisting of debentures, notes or other evidences of indebtedness; or |
| | | |
| ● | Any
combination of these securities. |
The
terms of any securities we offer will be determined at the time of sale. We may issue debt securities that are exchangeable for or convertible
into common stock or any of the other securities that may be sold under this prospectus. When particular securities are offered, a supplement
to this prospectus will be filed with the SEC, which will describe the terms of the offering and sale of the offered securities.
DESCRIPTION
OF OUR COMMON STOCK
Our
authorized capital stock consists of 200,000,000 shares of common stock, $0.01 par value per share, and 2,000,000 shares of preferred
stock, $0.01 par value per share, which may be issued in one or more series. The following summary of the terms of our common stock is
subject to and qualified in its entirety by reference to our restated certificate of incorporation (the “Certificate of Incorporation”)
and amended and restated bylaws (the “Bylaws”). Please refer to “Where You Can Find More Information; Incorporation
By Reference” below for directions on obtaining these documents.
As
of June 10, 2024, we had 40,962,694 shares of common stock outstanding and no shares of preferred stock outstanding.
General
Holders
of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and have the right
to vote cumulatively for the election of directors. This means that in the voting at our annual meeting, each stockholder or his proxy
may multiply the number of his shares by the number of directors to be elected, then cast the resulting total number of votes for a single
nominee, or distribute such votes on the ballot among the nominees as desired. Holders of our common stock are entitled to receive ratably
such dividends, if any, as may be declared by our Board of Directors (the “Board”) out of funds legally available therefor,
subject to any preferential dividend rights for our outstanding preferred stock.
Upon
our liquidation, dissolution, or winding up, the holders of our common stock are entitled to receive ratably our net assets available
after the payment of all debts and other liabilities and subject to the prior rights of any of our outstanding preferred stock. Holders
of our common stock have no preemptive, subscription, redemption, or conversion rights. The rights, preferences, and privileges of holders
of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred
stock which we may designate and issue in the future.
Our
common stockholders may not receive any assets or funds until our creditors have been paid in full and the preferential or participating
rights of our preferred stockholders have been satisfied. If we participate in a corporate merger, consolidation, purchase or acquisition
of property or stock, or other reorganization, any payments or shares of stock allocated to our common stockholders will be distributed
pro rata to holders of our common stock on a per share basis. If we redeem, repurchase, or otherwise acquire for payment any shares of
our common stock, we will treat each share of common stock identically.
We
may issue additional shares of our common stock, if authorized by the Board, without the common stockholders’ approval, unless
required by Delaware law or a stock exchange on which our securities are traded. If we receive the appropriate payment, shares of our
common stock that we issue will be fully paid and nonassessable.
Anti-Takeover
Provisions
We
are subject to the provisions of Section 203 of the General Corporation Law of Delaware (“DGCL”). Section 203 prohibits certain
publicly held Delaware corporations from engaging in a “business combination” with an “interested stockholder,”
for a period of three years after the date of the transaction in which the person became an “interested stockholder,” unless
the business combination is approved in a prescribed manner. A “business combination” includes mergers, asset sales and other
transactions resulting in a financial benefit to the interested stockholder. Subject to certain exceptions, an “interested stockholder”
is a person or entity who, together with affiliates and associates, owns (or within the preceding three years, did own) 15% or more of
the corporation’s voting stock. The statute contains provisions enabling a corporation to avoid the statute’s restrictions
if the stockholders holding a majority of the corporation’s voting stock approve the transaction. Moreover, our Certificate of
Incorporation provides that our directors shall be divided into three classes, with the terms of each class to expire in different years.
In
addition, our Certificate of Incorporation, in order to combat “greenmail,” provides in general that any direct or indirect
purchase by us of any of our voting stock or rights to acquire voting stock known to be beneficially owned by any person or group which
holds more than five percent of a class of our voting stock and which has owned the securities being purchased for less than two years
must be approved by the affirmative vote of at least two-thirds of the votes entitled to be cast by the holders of voting stock, subject
to certain exceptions. The prohibition of “greenmail” may tend to discourage or foreclose certain acquisitions of
our securities which might temporarily increase the price of our securities. Discouraging the acquisition of a large block of our securities
by an outside party may also have a potential negative effect on takeovers. Parties seeking control of us through large acquisitions
of our securities will not be able to resort to “greenmail” should their bid fail, thus making such a bid less attractive
to persons seeking to initiate a takeover effort.
Elimination
of Monetary Liability for Officers and Directors
Our
Certificate of Incorporation incorporates certain provisions permitted under DGCL relating to the liability of directors. The provisions
eliminate a director’s liability for monetary damages for a breach of fiduciary duty, including gross negligence, except in circumstances
involving certain wrongful acts, such as the breach of director’s duty of loyalty or acts or omissions involving intentional misconduct
or a knowing violation of law. These provisions do not eliminate a director’s duty of care. Moreover, these provisions do not apply
to claims against a director for certain violations of law, including knowing violations of federal securities law. Our Certificate of
Incorporation also contains provisions to indemnify the directors, officers, employees, or other agents to the fullest extent permitted
by DGCL. We believe that these provisions will assist us in attracting and retaining qualified individuals to serve as directors.
Our
Certificate of Incorporation also contains provisions to indemnify the directors, officers, employees, or other agents to the fullest
extent permitted by DGCL. These provisions may have the practical effect in certain cases of eliminating the ability of stockholders
to collect monetary damages from directors. We believe that these provisions will assist us in attracting or retaining qualified individuals
to serve as our directors.
The
Nasdaq Capital Market
Our
common stock is listed on Nasdaq under the symbol “ABEO.”
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Odyssey Transfer and Trust Company, headquartered in St. Paul, Minnesota.
DESCRIPTION
OF OUR PREFERRED STOCK
The
Board may, without further action by our stockholders, from time to time, direct the issuance of shares of preferred stock in series
and may, at the time of issuance, determine the rights, preferences, and limitations of each series, including voting rights, dividend
rights and redemption and liquidation preferences. Satisfaction of any dividend preferences of outstanding shares of our preferred stock
would reduce the amount of funds available for the payment of dividends on shares of our common stock. Holders of shares of our preferred
stock may be entitled to receive a preference payment in the event of any liquidation, dissolution or winding-up of our Company before
any payment is made to the holders of shares of our common stock. In some circumstances, the issuance of shares of preferred stock may
render more difficult or tend to discourage a merger, tender offer or proxy contest, the assumption of control by a holder of a large
block of our securities or the removal of incumbent management. Upon the affirmative vote of the Board, without stockholder approval,
we may issue shares of preferred stock with voting and conversion rights which could adversely affect the holders of shares of our common
stock.
If
we offer a specific class or series of preferred stock under this prospectus, we will describe the terms of the preferred stock in the
prospectus supplement for such offering and will file a copy of the certificate establishing the terms of the preferred stock with the
SEC. To the extent required, this description will include:
| ● | the
title and stated value; |
| | | |
| ● | the
number of shares offered, the liquidation preference per share and the purchase price; |
| | | |
| ● | the
dividend rate(s), period(s) and/or payment date(s) or method(s) of calculation for such dividends; |
| | | |
| ● | whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends
will accumulate; |
| | | |
| ● | the
procedures for any auction and remarketing, if any; |
| | | |
| ● | the
provisions for a sinking fund, if any; |
| | | |
| ● | the
provisions for redemption, if applicable; |
| | | |
| ● | any
listing of the preferred stock on any securities exchange or market; |
| | | |
| ● | whether
the preferred stock will be convertible into our common stock, and, if applicable, the conversion
price (or how it will be calculated), the conversion period and any other terms of conversion
(including any anti-dilution provisions, if any); |
| | | |
| ● | whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange
price (or how it will be calculated), the exchange period and any other terms of exchange
(including any anti-dilution provisions, if any); |
| | | |
| ● | voting
rights, if any, of the preferred stock; |
| | | |
| ● | a
discussion of any material U.S. federal income tax considerations applicable to the preferred
stock; |
| | | |
| ● | the
relative ranking and preferences of the preferred stock as to dividend rights and rights
upon liquidation, dissolution or winding up of the affairs of the Company; |
| | | |
| ● | any
material limitations on issuance of any class or series of preferred stock ranking senior
to or on parity with the series of preferred stock as to dividend rights and rights upon
liquidation, dissolution or winding up of the Company; and |
| | | |
| ● | any
other affirmative, negative, or other covenants or contractual rights which might be attendant
with the specific class or series of preferred stock. |
The
preferred stock offered by this prospectus, when issued, will not have, or be subject to, any preemptive or similar rights.
Transfer
Agent and Registrar
The
transfer agent and registrar for any series or class of preferred stock will be set forth in each applicable prospectus supplement.
DESCRIPTION
OF OUR WARRANTS
This
section describes the general terms and provisions of our warrants to acquire our securities that we may issue from time to time. The
applicable prospectus supplement will describe the specific terms of the warrants offered through that prospectus supplement.
We
may issue warrants for the purchase of our debt securities, common stock or preferred stock or other securities issued by us. We may
issue warrants independently or together with other securities, and they may be attached to or separate from the other securities. We
will file a copy of the warrant and warrant agreement with the SEC each time we issue a series of warrants, and these warrants and warrant
agreements will be incorporated by reference into the Registration Statement of which this prospectus is a part. A holder of our warrants
should refer to the provisions of the applicable warrant agreement and prospectus supplement for more specific information.
The
applicable prospectus supplement will contain, where applicable, the following terms of and other information relating to the warrants:
| ● | the
specific designation and aggregate number of, and the price at which we will issue, the warrants; |
| ● | the
currency or currency units in which the offering price, if any, and the exercise price are
payable; |
| ● | the
designation, amount, and terms of the securities purchasable upon exercise of the warrants; |
| ● | if
applicable, the exercise price for shares of our common stock and the number of shares of
common stock to be received upon exercise of the warrants; |
| ● | if
applicable, the exercise price for shares of our preferred stock, the number of shares of
preferred stock to be received upon exercise and a description of that class or series of
our preferred stock; |
| ● | if
applicable, the exercise price for our debt securities, the amount of our debt securities
to be received upon exercise and a description of that series of debt securities; |
| ● | the
date on which the right to exercise the warrants will begin and the date on which that right
will expire or, if the warrants may not be continuously exercised throughout that period,
the specific date or dates on which the warrants may be exercised; |
| ● | whether
the warrants will be issued in fully registered form or bearer form, in definitive or global
form or in any combination of these forms, although, in any case, the form of a warrant included
in a unit will correspond to the form of the unit and of any security included in that unit; |
| ● | any
applicable material U.S. federal income tax consequences; |
| ● | the
identity of the warrant agent for the warrants and of any other depositaries, execution or
paying agents, transfer agents, registrars, or other agents; |
| ● | the
proposed listing, if any, of the warrants or any securities purchasable upon exercise of
the warrants on any securities exchange; |
| ● | if
applicable, the date from and after which the warrants and the common stock, preferred stock
or debt securities will be separately transferable; |
| ● | if
applicable, the minimum or maximum amount of the warrants that may be exercised at any one
time; |
| ● | information
with respect to book-entry procedures, if any; |
| ● | any
redemption or call provisions; |
| ● | whether
the warrants are to be sold separately or with other securities as parts of units; and |
| ● | any
additional terms of the warrants, including terms, procedures and limitations relating to
the exchange and exercise of the warrants. |
After
your warrants expire they will become void. All warrants will be issued in registered form. The prospectus supplement may provide for
the adjustment of the exercise price of the warrants.
Warrants
may be exercised at the appropriate office of the warrant agent, or any other office indicated in the applicable prospectus supplement.
Before the exercise of warrants, holders will not have any of the rights of holders of the securities purchasable upon exercise and will
not be entitled to payments made to holders of those securities.
The
warrant agreements may be amended or supplemented without the consent of the holders of the warrants to which it applies to effect changes
that are not inconsistent with the provisions of the warrants and that do not materially and adversely affect the interests of the holders
of the warrants. However, any amendment that materially and adversely alters the rights of the holders of warrants will not be effective
unless the holders of at least a majority of the applicable warrants then outstanding approve the amendment. Every holder of an outstanding
warrant at the time any amendment becomes effective, by continuing to hold the warrant, will be bound by the applicable warrant agreement
as amended. The prospectus supplement applicable to a particular series of warrants may provide that certain provisions of the warrants,
including the securities for which they may be exercisable, the exercise price and the expiration date, may not be altered without the
consent of the holder of each warrant.
Transfer
Agent and Registrar
The
transfer agent and registrar for any warrants will be set forth in the applicable prospectus supplement.
DESCRIPTION
OF OUR DEBT SECURITIES
This
section describes the general terms and provisions of the debt securities that we may offer under this prospectus, any of which may be
issued as convertible or exchangeable debt securities. We will set forth the particular terms of the debt securities we offer in a prospectus
supplement. The extent, if any, to which the following general provisions apply to particular debt securities will be described in the
applicable prospectus supplement. The following description of general terms relating to the debt securities and the indenture under
which the debt securities will be issued are summaries only and therefore are not complete. You should read the indenture and the prospectus
supplement regarding any particular issuance of debt securities.
We
will issue any debt under an indenture to be entered into between us and the trustee identified in the applicable prospectus supplement.
The terms of the debt securities will include those stated in the indenture and those made part of the indenture by reference to the
Trust Indenture Act of 1939, as amended (the “Indenture Act”), as in effect on the date of the indenture. We have filed or
will file a copy of the form of indenture as an exhibit to the Registration Statement in which this prospectus is included. The indenture
will be subject to and governed by the terms of the Indenture Act.
We
may offer under this prospectus up to an aggregate principal amount of $300,000,000 in debt securities, or if debt securities
are issued at a discount, or in a foreign currency, foreign currency units or composite currency, the principal amount as may be sold
for an initial public offering price of up to $300,000,000. Unless otherwise specified in the applicable prospectus supplement, the debt
securities will represent direct, unsecured obligations of the Company and will rank equally with all of our other unsecured indebtedness.
The
following statements relating to the debt securities and the indenture are summaries, qualified in their entirety by reference to the
detailed provisions of the indenture and the final form indenture as may be filed with a future prospectus supplement.
General
We
may issue the debt securities in one or more series with the same or various maturities, at par, at a premium, or at a discount. We will
describe the particular terms of each series of debt securities in a prospectus supplement relating to that series, which we will file
with the SEC.
The
prospectus supplement will set forth, to the extent required, the following terms of the debt securities in respect of which the prospectus
supplement is delivered:
| ● | the
title of the series; |
| ● | the
aggregate principal amount; |
| ● | the
issue price or prices, expressed as a percentage of the aggregate principal amount of the
debt securities; |
| ● | any
limit on the aggregate principal amount; |
| ● | the
date or dates on which principal is payable; |
| ● | the
interest rate or rates (which may be fixed or variable) or, if applicable, the method used
to determine such rate or rates; |
| ● | the
date or dates from which interest, if any, will be payable and any regular record date for
the interest payable; |
| ● | the
place or places where principal and, if applicable, premium and interest, is payable; |
| ● | the
terms and conditions upon which we may, or the holders may require us to, redeem or repurchase
the debt securities; |
| ● | the
denominations in which such debt securities may be issuable, if other than denominations
of $1,000 or any integral multiple of that number; |
| ● | whether
the debt securities are to be issuable in the form of certificated securities (as described
below) or global securities (as described below); |
| ● | the
portion of principal amount that will be payable upon declaration of acceleration of the
maturity date if other than the principal amount of the debt securities; |
| ● | the
currency of denomination; |
| ● | the
designation of the currency, currencies, or currency units in which payment of principal
and, if applicable, premium and interest, will be made; |
| ● | if
payments of principal and, if applicable, premium or interest, on the debt securities are
to be made in one or more currencies or currency units other than the currency of denomination,
the manner in which the exchange rate with respect to such payments will be determined; |
| ● | if
amounts of principal and, if applicable, premium and interest may be determined by reference
to an index based on a currency or currencies or by reference to a commodity, commodity index,
stock exchange index or financial index, then the manner in which such amounts will be determined; |
| ● | the
provisions, if any, relating to any collateral provided for such debt securities; |
| ● | any
addition to or change in the covenants and/or the acceleration provisions described in this
prospectus or in the indenture; |
| ● | any
events of default, if not otherwise described below under “Defaults and Notice”; |
| ● | the
terms and conditions, if any, for conversion into or exchange for shares of our common stock
or preferred stock; |
| ● | any
depositaries, interest rate calculation agents, exchange rate calculation agents or other
agents; and |
| ● | the
terms and conditions, if any, upon which the debt securities shall be subordinated in right
of payment to other indebtedness of the Company. |
We
may issue discount debt securities that provide for an amount less than the stated principal amount to be due and payable upon acceleration
of the maturity of such debt securities in accordance with the terms of the indenture. We may also issue debt securities in bearer form,
with or without coupons. If we issue discount debt securities or debt securities in bearer form, we will describe material U.S. federal
income tax considerations and other material special considerations which apply to these debt securities in the applicable prospectus
supplement.
We
may issue debt securities denominated in or payable in a foreign currency or currencies or a foreign currency unit or units. If we do,
we will describe the restrictions, elections, and general tax considerations relating to the debt securities and the foreign currency
or currencies or foreign currency unit or units in the applicable prospectus supplement.
Exchange
and/or Conversion Rights
We
may issue debt securities which can be exchanged for or converted into shares of our common stock or preferred stock. If we do, we will
describe the terms of exchange or conversion in the prospectus supplement relating to these debt securities.
Transfer
and Exchange
We
may issue debt securities that will be represented by either:
| ● | “book-entry
securities,” which means that there will be one or more global securities registered
in the name of a depositary or a nominee of a depositary; or |
| ● | “certificated
securities,” which means that they will be represented by a certificate issued in definitive
registered form. |
We
will specify in the prospectus supplement applicable to a particular offering whether the debt securities offered will be book-entry
or certificated securities.
Certificated
Debt Securities
If
you hold certificated debt securities issued under an indenture, you may transfer or exchange such debt securities in accordance with
the terms of the indenture. You will not be charged a service charge for any transfer or exchange of certificated debt securities but
may be required to pay an amount sufficient to cover any tax or other governmental charge payable in connection with such transfer or
exchange.
Global
Securities
The
debt securities of a series may be issued in the form of one or more global securities that will be deposited with a depositary or its
nominees identified in the prospectus supplement relating to the debt securities. In such a case, one or more global securities will
be issued in a denomination or aggregate denominations equal to the portion of the aggregate principal amount of outstanding debt securities
of the series to be represented by such global security or securities.
Unless
and until it is exchanged in whole or in part for debt securities in definitive registered form, a global security may not be registered
for transfer or exchange except as a whole by the depositary for such global security to a nominee of the depositary and except in the
circumstances described in the prospectus supplement relating to the debt securities. The specific terms of the depositary arrangement
with respect to a series of debt securities will be described in the prospectus supplement relating to such series.
No
Protection in the Event of Change of Control
Any
indenture that governs our debt securities covered by this prospectus may not have any covenant or other provision providing for a put
or increased interest or otherwise that would afford holders of our debt securities additional protection in the event of a recapitalization
transaction, a change of control of the Company or a highly leveraged transaction. If we offer any covenants or provisions of this type
with respect to any debt securities covered by this prospectus, we will describe them in the applicable prospectus supplement.
Covenants
Unless
otherwise indicated in this prospectus or the applicable prospectus supplement, our debt securities may not have the benefit of any covenant
that limits or restricts our business or operations, the pledging of our assets or the incurrence by us of indebtedness. We will describe
in the applicable prospectus supplement any material covenants in respect of a series of debt securities.
Consolidation,
Merger, and Sale of Assets
We
may agree in any indenture that governs the debt securities of any series covered by this prospectus that we will not consolidate with
or merge into any other person or convey, transfer, sell or lease our properties and assets substantially as an entirety to any person,
unless such person and such proposed transaction meets various criteria, which we will describe in detail in the applicable prospectus
supplement.
Defaults
and Notice
The
debt securities of any series will contain events of default to be specified in the applicable prospectus supplement, which may include,
without limitation:
| ● | failure
to pay the principal of, or premium or make-whole amount, if any, on any debt security of
such series when due and payable (whether at maturity, by call for redemption, through any
mandatory sinking fund, by redemption at the option of the holder, by declaration or acceleration
or otherwise); |
| ● | failure
to make a payment of any interest on any debt security of such series when due; |
| ● | our
failure to perform or observe any other covenants or agreements in the indenture with respect
to the debt securities of such series; |
| ● | certain
events relating to our bankruptcy, insolvency, or reorganization; and |
| ● | certain
cross defaults, if and as applicable. |
If
an event of default with respect to debt securities of any series shall occur and be continuing, we may agree that the trustee or the
holders of at least 25% in aggregate principal amount of the then outstanding debt securities of such series may declare the principal
amount (or, if the debt securities of such series are issued at an original issue discount, such portion of the principal amount as may
be specified in the terms of the debt securities of such series) of all debt securities of such series or such other amount or amounts
as the debt securities or supplemental indenture with respect to such series may provide, to be due and payable immediately. Any provisions
pertaining to events of default and any remedies associated therewith will be described in the applicable prospectus supplement.
Any
indenture that governs our debt securities covered by this prospectus may require that the trustee under such indenture shall, within
90 days after the occurrence of a default, give to holders of debt securities of any series notice of all uncured defaults with respect
to such series known to it. However, in the case of a default that results from the failure to make any payment of the principal of,
premium or make-whole amount, if any, or interest on the debt securities of any series, or in the payment of any mandatory sinking fund
installment with respect to debt securities of such series, if any, the trustee may withhold such notice if it in good faith determines
that the withholding of such notice is in the interest of the holders of debt securities of such series. Any terms and provisions relating
to the foregoing types of provisions will be described in further detail in the applicable prospectus supplement.
Any
indenture that governs our debt securities covered by this prospectus will contain a provision entitling the trustee to be indemnified
by holders of debt securities before proceeding to exercise any trust or power under the indenture at the request of such holders. Any
such indenture may provide that the holders of at least a majority in aggregate principal amount of the then outstanding debt securities
of any series may direct the time, method, and place of conducting any proceedings for any remedy available to the trustee, or of exercising
any trust or power conferred upon the trustee with respect to the debt securities of such series. However, the trustee under any such
indenture may decline to follow any such direction if, among other reasons, the trustee determines in good faith that the actions or
proceedings as directed may not lawfully be taken, would involve the trustee in personal liability or would be unduly prejudicial to
the holders of the debt securities of such series not joining in such direction.
Any
indenture that governs our debt securities covered by this prospectus may endow the holders of such debt securities to institute a proceeding
with respect to such indenture, subject to certain conditions, which will be specified in the applicable prospectus supplement and which
may include, that the holders of at least a majority in aggregate principal amount of the debt securities of such series then outstanding
make a written request upon the trustee to exercise its power under the indenture, indemnify the trustee and afford the trustee reasonable
opportunity to act. Even so, such holders may have an absolute right to receipt of the principal of, premium or make-whole amount, if
any, and interest when due, to require conversion or exchange of debt securities if such indenture provides for convertibility or exchangeability
at the option of the holder and to institute suit for the enforcement of such rights. Any terms and provisions relating to the foregoing
types of provisions will be described in further detail in the applicable prospectus supplement.
Modification
of the Indenture
We
and the trustee may modify any indenture that governs our debt securities of any series covered by this prospectus with or without the
consent of the holders of such debt securities, under certain circumstances to be described in a prospectus supplement.
Defeasance;
Satisfaction and Discharge
The
prospectus supplement will outline the conditions under which we may elect to have certain of our obligations under the indenture discharged
and under which the indenture obligations will be deemed to be satisfied.
Regarding
the Trustee
We
will identify the trustee and any relationship that we may have with such trustee, with respect to any series of debt securities, in
the prospectus supplement relating to the applicable debt securities. You should note that if the trustee becomes a creditor of the Company,
the indenture and the Indenture Act limit the rights of the trustee to obtain payment of claims in certain cases, or to realize on certain
property received in respect of any such claim, as security or otherwise. The trustee and its affiliates may engage in, and will be permitted
to continue to engage in, other transactions with us and our affiliates. If, however, the trustee acquires any “conflicting interest”
within the meaning of the Indenture Act, it must eliminate such conflict or resign.
Governing
Law
The
law governing the indenture and the debt securities will be identified in the prospectus supplement relating to the applicable indenture
and debt securities.
WHERE
YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
We
file annual, quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains a website at www.sec.gov
that contains reports, statements, and other information about issuers, such as us, who file electronically with the SEC. We maintain
a website at www.abeonatherapeutics.com. However, the information on our website is not incorporated by reference into this prospectus
and any prospectus supplement and you should not consider it a part of this prospectus or any accompanying prospectus supplement.
The
SEC allows us to “incorporate by reference” into this prospectus the information in other documents that we file with it.
This means that we can disclose important information to you by referring you to those documents. The information incorporated by reference
is considered to be a part of this prospectus, and information in documents that we file later with the SEC will automatically update
and supersede information contained in documents filed earlier with the SEC or contained in this prospectus. We incorporate by reference
into this prospectus the documents listed below; provided, however, that we are not incorporating, in each case, any documents or information
deemed to have been furnished and not filed in accordance with SEC rules:
| |
● |
our
Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 18, 2024; |
| |
|
|
| |
● |
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed on May 15, 2024; |
| |
|
|
| |
● |
the
portions of our definitive proxy statement on Schedule 14A filed on March 19, 2024 that are incorporated by reference into Part III
of our Annual Report on Form 10-K for the year ended December 31, 2023; |
| |
|
|
| |
● |
our
Current Reports on Form 8-K filed on January 8, 2024, April 22, 2024, April 24, 2024, and May 3, 2024; and |
| |
|
|
| |
● |
the
description of our common stock, par value $0.01 per share contained in our Registration Statement on Form 8-A, dated and filed with
the SEC on November 4, 2014, as updated by Exhibit 4.4 to our Form 10-K for the fiscal year ended December 31, 2019, and including
any amendments or reports filed with the SEC for the purpose of updating such description. |
All
reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination
of this offering, including all such documents we may file with the SEC after the date of this initial registration statement and prior
to the effectiveness of this registration statement, but excluding any information furnished to and not filed with, the SEC, will also
be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports
and documents.
You
may obtain a copy of any or all of the documents referred to above which may have been or may be incorporated by reference into this
prospectus, except for exhibits to those documents (unless the exhibits are specifically incorporated by reference into those documents)
at no cost to you by contacting us at the following address and telephone number: Investor Relations, Abeona Therapeutics Inc., 6555
Carnegie Avenue, 4th Floor, Cleveland, Ohio 44103, telephone (646) 813-4701.
LEGAL
MATTERS
Unless
otherwise specified in the prospectus supplement accompanying this prospectus, Willkie Farr & Gallagher LLP will provide opinions
regarding certain legal matters. Certain partners and attorneys of Willkie Farr & Gallagher LLP hold shares of our common stock.
Additional legal matters may be passed upon for us or any underwriters, dealers, or agents by counsel that we will name in the applicable
prospectus supplement.
EXPERTS
The
financial statements of Abeona Therapeutics, Inc. as of December 31, 2023, and for the year ended December 31, 2023, incorporated by
reference in this prospectus by reference to Abeona Therapeutics, Inc.’s annual report on Form 10-K for the year ended December
31, 2023, have been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their
report. Such financial statements are incorporated by reference in reliance upon the report of such firm given their authority as experts
in accounting and auditing.
The
consolidated financial statements for the fiscal year ended December 31, 2022, incorporated by reference from the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2023, have been audited by Whitley Penn LLP, an independent registered public
accounting firm, as stated in its report filed with the Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2023, which is also incorporated herein by reference. Such financial statements have been so incorporated in reliance upon the report
of such firm given upon their authority as experts in accounting and auditing.
THE
INFORMATION IN THIS PROSPECTUS MAY CHANGE OR BE AMENDED. WE MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IS NOT SOLICITING AN
OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT
TO COMPLETION, DATED JUNE 17, 2024
Prospectus
$75,000,000
Common
Stock
We
have entered into an Open Market Sale AgreementSM dated August 17, 2018, as amended on November 19, 2021 (the “Sale
Agreement”), with Jefferies LLC (the “Agent”), relating to the sale of shares of our common stock offered by this prospectus.
In accordance with the terms of the Sale Agreement, we may offer and sell shares of our common stock under this prospectus having an
aggregate offering price of up to $75,000,000.
Sales
of our common stock, if any, under this prospectus may be made in sales deemed to be “at the market offerings” as defined
in Rule 415 promulgated under the Securities Act of 1933, as amended (“the Securities Act”) including sales made directly
on or through the Nasdaq Capital Market, the existing trading market for our common stock, sales made to or through a market maker other
than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to
such prevailing market prices, and/or any other method permitted by law. The Agent is not required to sell any specific number or dollar
amount of securities but will act as our sales agent using commercially reasonable efforts consistent with its normal trading and sales
practices, on mutually agreed terms between the Agent and us. Our common stock to which this prospectus relates will be sold through
the Agent on any given day. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
The
compensation to the Agent for sales of common stock sold pursuant to the Sale Agreement will be 3.0% of the gross proceeds from each
such sale. In connection with the sale of the common stock on our behalf, the Agent may be deemed to be an “underwriter”
within the meaning of the Securities Act, and the Agent’s compensation may be deemed to be underwriting commissions or discounts.
See “Plan of Distribution” for additional information regarding compensation to be paid to the Agent. We have also agreed
to provide indemnification and contribution to the Agent with respect to certain liabilities, including liabilities under the Securities
Act.
Our
common stock is listed on the Nasdaq Capital Market under the symbol “ABEO.” On June 10, 2024, the last reported sale price
of our common stock on the Nasdaq Capital Market was $4.46 per share.
Investing
in our securities involves significant risks. Please read the information contained in or incorporated by reference under the heading
“Risk Factors” beginning on page S-5 of this prospectus, and under similar headings in other documents filed after the
date hereof and incorporated by reference into this prospectus and any free writing prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed
upon the adequacy or accuracy of this prospectus or any free writing prospectus prospectus. Any representation to the contrary is a criminal
offense.
Jefferies
LLC
The
date of this prospectus is June , 2024
Table
of Contents
ABOUT
THIS PROSPECTUS
This
prospectus relates to the offering of our common stock. You should read this prospectus, the documents incorporated by reference into
this prospectus, and any free writing prospectus that we may authorize for use in connection with this offering, in their entirety before
making an investment decision. You should also read and consider the information in the documents to which we have referred you in the
section of this prospectus entitled “Where You Can Find More Information; Incorporation by Reference.” These documents contain
important information that you should consider when making your investment decision.
To
the extent there is a conflict between the information contained in this prospectus, on the one hand, and the information contained in
any document incorporated by reference that was filed with the SEC before the date of this prospectus, on the other hand, you should
rely on the information in this prospectus. If any statement in one of these documents is inconsistent with a statement in another document
having a later date — for example, a document incorporated by reference in this prospectus — the statement in the document
having the later date modifies or supersedes the earlier statement.
We
are responsible for the information contained in, or incorporated by reference into, this prospectus and in any free writing prospectus
that we may authorize for use in connection with this offering. We have not, and the Agent has not, authorized any other person to provide
you with different information, and neither we nor the Agent takes any responsibility for any other information that others may give
you.
We
are not, and the Agent is not, making an offer to sell or soliciting an offer to buy our common stock in any jurisdiction in which an
offer or solicitation is not authorized or in which the person making that offer or solicitation is not qualified to do so or to anyone
to whom it is unlawful to make an offer or solicitation.
You
should assume that the information appearing in this prospectus, the documents incorporated by reference into this prospectus, and in
any free writing prospectus that we may authorize for use in connection with this offering, is accurate only as of the date of those
respective documents. Our business, financial condition, results of operations and prospects may have changed since those dates.
Unless
the context otherwise requires or as otherwise expressly stated, references in this prospectus to the terms “the Company,”
“Abeona,” “we,” “our” and “us” or other similar terms mean Abeona Therapeutics Inc. and
its subsidiaries, unless we state otherwise, or the context indicates otherwise.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the other documents we have filed with the SEC that are incorporated herein by reference contain forward-looking statements
that involve substantial risks and uncertainties. All statements, other than statements of historical facts, regarding our strategy,
future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management or other financial
items are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,”
“seek,” “intend,” “may,” “plan,” “predict,” “project,” “will,”
“would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words.
We
may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this
prospectus, particularly as set forth and incorporated by reference in the “Risk Factors” section below, that we believe
could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements
do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations, or investments
we may make. You should read this prospectus and the documents that we incorporate by reference in this prospectus completely and with
the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to
update any forward-looking statements, except as otherwise required by law. We advise you, however, to consult any further disclosures
we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K
we file with or furnish to the SEC.
SUMMARY
This
summary highlights information contained elsewhere or incorporated by reference in this prospectus. This summary does not contain all
of the information that you should consider before deciding to invest in our common stock. You should read this entire prospectus carefully,
including the “Risk Factors” section contained in this prospectus, our financial statements and the related notes thereto,
and the other documents incorporated by reference in this prospectus.
Overview
We
are a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. Our lead clinical program
is pz-cel, investigational autologous, COL7A1 gene-corrected epidermal sheets, currently in development for recessive dystrophic epidermolysis
bullosa (“RDEB”). We have announced positive data from our VIITAL™ Phase 3 study evaluating the efficacy, safety and
tolerability of pz-cel. The VIITAL™ study met its two co-primary efficacy endpoints demonstrating statistically significant, clinically
meaningful improvements in wound healing and pain reduction in large chronic RDEB wounds. On September 25, 2023, we submitted a Biologics
License Application (“BLA”) for pz-cel to the U.S. Food and Drug Administration (“FDA”).
In
November 2023, the FDA accepted and granted priority review for our BLA for pz-cel, and subsequently, under the Prescription Drug User
Fee Act (“PDUFA”), the FDA set a target action date of May 25, 2024. However, in April 2024, the FDA issued a Complete Response
Letter (“CRL”) in response to the BLA. The CRL follows the completion of Abeona’s Late Cycle Review Meeting with the
FDA in March 2024. At the Late Cycle Review Meeting and in a subsequent information request, the FDA noted that certain additional information
needed to satisfy Chemistry Manufacturing and Controls (“CMC”) requirements must be satisfactorily resolved before the application
can be approved. In response, we submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval, and full validation
reports after approval in mid-2024. In addition, the Company discussed these plans with the FDA in a subsequent informal meeting. In
the CRL, the FDA indicated that the proposed timing of the data submission by us would not allow sufficient time for the FDA to complete
its review by the May 25, 2024 PDUFA date.
The
information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing
methods, including some that were captured in the observations during the FDA’s pre-license inspection (“PLI”). The
CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request
any new clinical trials or clinical data to support the approval of pz-cel. We anticipate completing and submitting the requested CMC
information in the second half of 2024.
We
have continued to prepare our current Good Manufacturing Practices (“cGMP”) commercial facility in Cleveland, Ohio for manufacturing
pz-cel drug product to support our planned commercial launch of pz-cel, if approved. Pz-cel study drug product for all our VIITAL™
study participants has been manufactured at our Cleveland facility. As part of our commercial planning, we continue to engage with stakeholders
across the healthcare system, including public and private payors, and healthcare providers to better understand market access and potential
pricing for pz-cel. We have also begun discussions with high volume treatment centers of excellence to onboard them for pz-cel application
upon potential FDA approval.
Our
development portfolio also features adeno-associated virus (“AAV”) based gene therapies designed to treat ophthalmic diseases
using the novel AIM™ capsid platform that we have exclusively licensed from the University of North Carolina at Chapel Hill, and
internal AAV vector research programs.
Preclinical
Pipeline
Our
preclinical programs are investigating the use of novel AAV capsids in AAV-based therapies for serious genetic eye diseases, including
ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (“XLRS”) and ABO-505 for autosomal dominant optic atrophy
(“ADOA”). We have completed pre-Investigational New Drug Application meetings with the FDA regarding our preclinical development
plans and regulatory requirements to support first-in-human trials.
Company
Information
We
were incorporated in 1974. On October 24, 2014, we changed our name to PlasmaTech Biopharmaceuticals, Inc., and on June 19, 2015, we
changed our name to Abeona Therapeutics Inc. to reflect our broader rare disease commitment. Our principal executive office is located
at 6555 Carnegie Avenue, 4th Floor, Cleveland, Ohio 44103, and our telephone number is (646) 813-4701. Our website address
is www.abeonatherapeutics.com. We do not incorporate by reference into this prospectus the information on our website, and you should
not consider it as part of this prospectus.
THE
OFFERING
| Common
Stock Offered |
|
Shares
of our common stock having an aggregate offering price of up to $75,000,000. |
| |
|
|
| Manner
of Offering |
|
“At
the market offering” that may be made from time to time through the Agent, as sales agent. See “Plan of Distribution”
on page S-10 of this prospectus for a more complete description of the manner of offering. |
| |
|
|
| Sales
Agent |
|
Jefferies
LLC |
| |
|
|
| Use
of Proceeds |
|
We
intend to use the net proceeds from this offering primarily to fund preparations for resubmission of our BLA and for commercialization
of our product candidate pz-cel, as well as for working capital and general corporate purposes. The amounts and timing of our use
of the net proceeds from the sale of securities in this offering will depend on a number of factors, such as regulatory approvals,
commercial infrastructure expansion, the timing and progress of our pre-clinical product candidates and our development efforts,
technological advances and the competitive environment for our product candidates. See “Use of Proceeds” on page S-6
of this prospectus for a more complete description of the intended use of proceeds from this offering. |
| |
|
|
| Risk
Factors |
|
Investing
in our securities involves significant risks. Please read the information contained in or incorporated by reference under the heading
“Risk Factors” beginning on page S-5 of this prospectus, and under similar headings in other documents filed after
the date hereof and incorporated by reference into this prospectus. |
| |
|
|
| Nasdaq
Capital Market symbol |
|
ABEO |
RISK
FACTORS
An
investment in our securities involves risks. We urge you to consider carefully the risks described below, and in the documents incorporated
by reference in this prospectus, before making an investment decision, including those risks identified under “Item IA. Risk Factors”
in our Annual Report on Form 10-K for the year ended December 31, 2023 and in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2024, which are incorporated by reference in this prospectus and which may be amended, supplemented or superseded from time
to time by other reports that we subsequently file with the SEC. Additional risks, including those that relate to any particular securities
we offer, may be included in a future prospectus supplement or free writing prospectus that we authorize from time to time, or incorporated
by reference into this prospectus in connection with this offering. If any of these risks actually occur, our business, financial condition,
results of operations or cash flow could be seriously harmed. This could cause the trading price of our common stock to decline, resulting
in a loss of all or part of your investment. Please also read carefully the section below entitled “Special Note Regarding Forward-Looking
Statements.”
Risks
Related to this Offering
Sales
of our common stock in this offering, or the perception that such sales may occur, could cause the market price of our common stock to
fall.
The
issuance and sale from time to time of shares of common stock, or our ability to issue these new shares of common stock in this offering,
could have the effect of depressing the market price of our common stock. We cannot predict the effect that future sales of our common
stock would have on the market price of our common stock.
Our
management will have broad discretion over the use of the net proceeds from this offering, you may not agree with how we use the proceeds,
and the proceeds may not be invested successfully.
Our
management will have broad discretion as to the use of the net proceeds from any offering by us and could use them for purposes other
than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard
to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds
are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return
for Abeona.
You
may experience immediate and substantial dilution in the book value per share of the common stock you purchase in the offering.
The
offering price per share in this offering may exceed the pro forma net tangible book value per share of our common stock outstanding
prior to this offering. Based on an assumed public offering price of $4.46 per share, which was the last reported sale price of our common
stock on the Nasdaq Capital Market on June 10, 2024, you will experience immediate dilution of $3.12 per share, representing the
difference between our pro forma as adjusted net tangible book value per share as of March 31, 2024, after giving effect to this offering
and the assumed offering price. The exercise of outstanding stock options will result in further dilution of your investment. See the
section below entitled “Dilution” for a more detailed illustration of the dilution you would incur if you participate in
this offering.
We
will require additional capital funding, the receipt of which may impair the value of our common stock.
Our
future capital requirements depend on many factors, including our research, development, sales, and marketing activities. We will need
to raise additional capital through public or private equity or debt offerings or through arrangements with strategic partners or other
sources in order to continue to develop our drug candidates. There can be no assurance that additional capital will be available when
needed or on terms satisfactory to us, if at all. To the extent we raise additional capital by issuing equity securities, our stockholders
may experience substantial dilution and the new equity securities may have greater rights, preferences, or privileges than our existing
common stock.
USE
OF PROCEEDS
We
intend to use the net proceeds from this offering primarily to fund preparations for resubmission of our BLA and for commercialization
of our product candidate pz-cel, as well as for working capital and general corporate purposes. The amounts and timing of our use of
the net proceeds from the sale of securities in this offering will depend on a number of factors, such as regulatory approvals, commercial
infrastructure expansion, the timing and progress of our pre-clinical product candidates and our development efforts, technological advances
and the competitive environment for our product candidates.
As
of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering.
Accordingly, our management will have broad discretion in the timing and application of these proceeds. Pending application of the net
proceeds as described above, we may invest the net proceeds of this offering in a variety of capital preservation investments, including
but not limited to short-term, interest-bearing investment grade government securities, money market accounts, certificates of deposit
and direct or guaranteed obligations of the U.S. government.
DILUTION
If
you invest in this offering, your ownership interest will be diluted to the extent of the difference between the price per share you
pay in this offering and the net tangible book value per share of our common stock immediately after this offering. The net tangible
book value of our common stock as of March 31, 2024, was approximately $(13.1) million, or approximately $(0.48) per share of common
stock based upon 27,550,593 shares outstanding. Net tangible book value per share is equal to our total tangible assets, less our total
liabilities, divided by the total number of shares outstanding as of March 31, 2024.
Without
taking into account any other changes in net tangible book value after March 31, 2024, after giving effect to the sale of our common
stock pursuant to this prospectus in the aggregate amount of $75,000,000 at an assumed offering price of $4.46 per share, the last reported
sale price of our common stock on the Nasdaq Capital Market on June 10, 2024, and after deducting commissions and estimated aggregate
offering expenses payable by us, our net tangible book value as of March 31, 2024 would have been $59.5 million, or $1.34
per share of common stock. This represents an immediate increase in the net tangible book value of $1.82 per share to our existing
stockholders and an immediate dilution in net tangible book value of $3.12 per share to new investors. The following table illustrates
this per share dilution:
| Assumed offering price per share | |
| | | |
$ | 4.46 | |
| Net tangible book value per share as of March 31, 2024 | |
$ | (0.48 | ) | |
| | |
| Increase per share attributable to new investors | |
$ | 1.82 | | |
| | |
| As adjusted net tangible book value per share as of March 31, 2024 after giving effect to this offering | |
| | | |
$ | 1.34 | |
| Dilution per share to new investors purchasing shares in this offering | |
| | | |
$ | 3.12 | |
The
number of shares of our common stock to be outstanding after this offering is based on 27,550,593 shares of our common stock outstanding
as of March 31, 2024, which amount excludes:
| |
● |
179,001
shares issuable upon the exercise of stock options outstanding as of March 31, 2024, at a weighted average exercise price of $38.58
per share; |
| |
|
|
| |
● |
42,700
shares of common stock issued under our equity
incentive plans after March 31, 2024; |
| |
|
|
| |
● |
1,717,591
shares of common stock reserved for future issuance under our amended and restated 2023 equity incentive plan; |
| |
|
|
| |
● |
719,700
shares of common stock reserved for future issuance
under our inducement equity incentive plan; |
| |
|
|
| |
● |
9,397,897
shares of common stock issuable upon the exercise of warrants outstanding as of March 31, 2024, at a weighted average exercise price
of $5.70 per share, subject to customary adjustments thereunder; |
| |
|
|
| |
● |
2,919,140
shares of common stock issuable upon the exercise of pre-funded warrants outstanding as of March 31, 2024, at an exercise price of
$0.0001; |
| |
|
|
| |
● |
589,681
shares of common stock issuable upon the exercise of warrants issued in connection with our credit facility entered into on January
8, 2024, at an exercise price of the lesser of $4.07 per share and the effective price per share of any bona fide equity financing
with gross proceeds in excess of $10,000,000 that occurs before September 30, 2024; |
| |
|
|
| |
● |
12,285,056
shares of common stock issued in connection with our underwritten offering that closed on May 7, 2024; and |
| |
|
|
| |
● |
6,142,656
shares of common stock issuable upon the exercise of pre-funded warrants issued in connection with our underwritten offering that
closed on May 7, 2024, at an exercise price of $0.0001; |
DESCRIPTION
OF OUR COMMON STOCK
Our
authorized capital stock consists of 200,000,000 shares of common stock, $0.01 par value per share, and 2,000,000 shares of preferred
stock, $0.01 par value per share, which may be issued in one or more series. The following summary of the terms of our common stock is
subject to and qualified in its entirety by reference to our restated certificate of incorporation (the “Certificate of Incorporation”)
and amended and restated bylaws (the “Bylaws”). Please refer to “Where You Can Find More Information; Incorporation
By Reference” below for directions on obtaining these documents.
As
of June 10, 2024, we had 40,962,694 shares of common stock outstanding and no shares of preferred stock outstanding.
General
Holders
of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and have the right
to vote cumulatively for the election of directors. This means that in the voting at our annual meeting, each stockholder or his proxy
may multiply the number of his shares by the number of directors to be elected, then cast the resulting total number of votes for a single
nominee, or distribute such votes on the ballot among the nominees as desired. Holders of our common stock are entitled to receive ratably
such dividends, if any, as may be declared by our Board of Directors (the “Board”) out of funds legally available therefor,
subject to any preferential dividend rights for our outstanding preferred stock.
Upon
our liquidation, dissolution, or winding up, the holders of our common stock are entitled to receive ratably our net assets available
after the payment of all debts and other liabilities and subject to the prior rights of any of our outstanding preferred stock. Holders
of our common stock have no preemptive, subscription, redemption, or conversion rights. The rights, preferences, and privileges of holders
of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of our preferred
stock which we may designate and issue in the future.
Our
common stockholders may not receive any assets or funds until our creditors have been paid in full and the preferential or participating
rights of our preferred stockholders have been satisfied. If we participate in a corporate merger, consolidation, purchase or acquisition
of property or stock, or other reorganization, any payments or shares of stock allocated to our common stockholders will be distributed
pro rata to holders of our common stock on a per share basis. If we redeem, repurchase, or otherwise acquire for payment any shares of
our common stock, we will treat each share of common stock identically.
We
may issue additional shares of our common stock, if authorized by the Board, without the common stockholders’ approval, unless
required by Delaware law or a stock exchange on which our securities are traded. If we receive the appropriate payment, shares of our
common stock that we issue will be fully paid and nonassessable.
Anti-Takeover
Provisions
We
are subject to the provisions of Section 203 of the General Corporation Law of Delaware (“DGCL”). Section 203 prohibits certain
publicly held Delaware corporations from engaging in a “business combination” with an “interested stockholder,”
for a period of three years after the date of the transaction in which the person became an “interested stockholder,” unless
the business combination is approved in a prescribed manner. A “business combination” includes mergers, asset sales and other
transactions resulting in a financial benefit to the interested stockholder. Subject to certain exceptions, an “interested stockholder”
is a person or entity who, together with affiliates and associates, owns (or within the preceding three years, did own) 15% or more of
the corporation’s voting stock. The statute contains provisions enabling a corporation to avoid the statute’s restrictions
if the stockholders holding a majority of the corporation’s voting stock approve the transaction. Moreover, our Certificate of
Incorporation provides that our directors shall be divided into three classes, with the terms of each class to expire in different years.
In
addition, our Certificate of Incorporation, in order to combat “greenmail,” provides in general that any direct or indirect
purchase by us of any of our voting stock or rights to acquire voting stock known to be beneficially owned by any person or group which
holds more than five percent of a class of our voting stock and which has owned the securities being purchased for less than two years
must be approved by the affirmative vote of at least two-thirds of the votes entitled to be cast by the holders of voting stock, subject
to certain exceptions. The prohibition of “greenmail” may tend to discourage or foreclose certain acquisitions of
our securities which might temporarily increase the price of our securities. Discouraging the acquisition of a large block of our securities
by an outside party may also have a potential negative effect on takeovers. Parties seeking control of us through large acquisitions
of our securities will not be able to resort to “greenmail” should their bid fail, thus making such a bid less attractive
to persons seeking to initiate a takeover effort.
Elimination
of Monetary Liability for Officers and Directors
Our
Certificate of Incorporation incorporates certain provisions permitted under DGCL relating to the liability of directors. The provisions
eliminate a director’s liability for monetary damages for a breach of fiduciary duty, including gross negligence, except in circumstances
involving certain wrongful acts, such as the breach of director’s duty of loyalty or acts or omissions involving intentional misconduct
or a knowing violation of law. These provisions do not eliminate a director’s duty of care. Moreover, these provisions do not apply
to claims against a director for certain violations of law, including knowing violations of federal securities law. Our Certificate of
Incorporation also contains provisions to indemnify the directors, officers, employees, or other agents to the fullest extent permitted
by DGCL. We believe that these provisions will assist us in attracting and retaining qualified individuals to serve as directors.
Our
Certificate of Incorporation also contains provisions to indemnify the directors, officers, employees, or other agents to the fullest
extent permitted by DGCL. These provisions may have the practical effect in certain cases of eliminating the ability of stockholders
to collect monetary damages from directors. We believe that these provisions will assist us in attracting or retaining qualified individuals
to serve as our directors.
The
Nasdaq Capital Market
Our
common stock is listed on Nasdaq under the symbol “ABEO.”
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Odyssey Transfer and Trust Company, St. Paul, Minnesota.
PLAN
OF DISTRIBUTION
We
have entered into an Open Market Sale AgreementSM, as amended by Amendment No. 1 thereto, dated as of November 19, 2021, with
Jefferies LLC (the “Agent”), under which we may issue and sell shares of our common stock from time to time through the Agent
acting as sales agent, subject to certain limitations, including the number of shares registered under the registration statement to
which the offering relates, we may offer and sell shares of our common stock under this prospectus having an aggregate offering price
of up to $75,000,000.
Sales
of our common stock, if any, under this prospectus may be made in sales deemed to be “at the market offerings” as defined
in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Capital Market, the existing
trading market for our common stock, sales made to or through a market maker other than on an exchange or otherwise, in negotiated transactions
at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted
by law. We may instruct the Agent not to sell our common stock if the sales cannot be effected at or above the price designated by us
from time to time. We or the Agent may suspend the offering of our common stock upon notice and subject to other conditions. As an agent,
the Agent will not engage in any transactions that stabilize the price of our common stock. Our common stock to which this prospectus
relates will be sold through only one Agent on any given day.
Each
time we wish to issue and sell common stock under the Sale Agreement with the Agent, we will notify the Agent of the number of shares
to be issued, the dates on which such sales are anticipated to be made, any minimum price below which sales may not be made and other
sales parameters as we deem appropriate. Once we have so instructed the Agent, unless the Agent declines to accept the terms of the notice,
the Agent has agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such shares
up to the amount specified on such terms. The Agent’s obligations under the Sale Agreement to sell our common stock are subject
to a number of conditions that we must meet.
We
will pay the Agent commissions for its services in acting as agent in the sale of our common stock. The Agent will be entitled to compensation
at a commission rate equal to 3.0% of the gross sales price per share sold. Because there is no minimum offering amount required as a
condition to closing this offering, the actual total public offering amount, commissions, and proceeds to us, if any, are not determinable
at this time. In addition, we reimbursed the Agent for $50,000 of fees and disbursements paid to its legal counsel in connection with
each of the original Sale Agreement and Amendment No. 1 thereto. In accordance with FINRA Rule 5110, these reimbursed fees and expenses
are deemed sales compensation for this offering.
We
estimate that the total expenses for the offering, excluding compensation and reimbursed fees and expenses payable to Agent under the
terms of the Sale Agreement and Amendment No. 1 thereto, will be approximately $178,000.
Settlement
for sales of our common stock will occur on the second business day following the date on which any sales are made, or on some other
date that is agreed upon by us and the Agent in connection with a particular transaction, in return for payment of the net proceeds to
us. There is no arrangement for funds to be received in an escrow, trust, or similar arrangement.
In
connection with the sale of the common stock on our behalf, the Agent may, and will with respect to sales effected in an “at the
market offering,” be deemed to be an “underwriter” within the meaning of the Securities Act, and the Agent’s
compensation may be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution to
the Agent against certain civil liabilities, including liabilities under the Securities Act.
The
offering pursuant to the Sale Agreement will terminate upon the earlier of (i) the issuance and sale of all shares of our common stock
subject to the Sale Agreement, or (ii) the termination of the Sale Agreement as permitted therein.
The
Agent and its affiliates may in the future provide various investment banking and other financial services for us and our affiliates,
for which services they may in the future receive customary fees. To the extent required by Regulation M, the Agent will not engage in
any market making activities involving our common stock while the offering is ongoing under this prospectus.
WHERE
YOU CAN FIND MORE INFORMATION; INCORPORATION BY REFERENCE
We
file annual, quarterly and current reports, proxy statements and other information with the SEC. The SEC maintains a website at www.sec.gov
that contains reports, statements, and other information about issuers, such as us, who file electronically with the SEC. We maintain
a website at www.abeonatherapeutics.com. However, the information on our website is not incorporated by reference into this prospectus
and any prospectus supplement and you should not consider it a part of this prospectus or any accompanying prospectus supplement.
The
SEC allows us to “incorporate by reference” into this prospectus the information in other documents that we file with it.
This means that we can disclose important information to you by referring you to those documents. The information incorporated by reference
is considered to be a part of this prospectus, and information in documents that we file later with the SEC will automatically update
and supersede information contained in documents filed earlier with the SEC or contained in this prospectus. We incorporate by reference
into this prospectus the documents listed below; provided, however, that we are not incorporating, in each case, any documents or information
deemed to have been furnished and not filed in accordance with SEC rules:
| |
● |
our
Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 18, 2024; |
| |
|
|
| |
● |
our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed on May 15, 2024; |
| |
|
|
| |
● |
the
portions of our definitive proxy statement on Schedule 14A filed on March 19, 2024 that are incorporated by reference into Part III
of our Annual Report on Form 10-K for the year ended December 31, 2023; |
| |
|
|
| |
● |
our
Current Reports on Form 8-K filed on January 8, 2024, April 22, 2024, April 24, 2024, and May 3, 2024; and |
| |
|
|
| |
● |
the
description of our common stock, par value $0.01 per share contained in our Registration Statement on Form 8-A, dated and filed with
the SEC on November 4, 2014, as updated by Exhibit 4.4 to our Form 10-K for the fiscal year ended December 31, 2019, and including
any amendments or reports filed with the SEC for the purpose of updating such description. |
All
reports and other documents we subsequently file pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act prior to the termination
of this offering, including all such documents we may file with the SEC after the date of this initial registration statement and prior
to the effectiveness of this registration statement, but excluding any information furnished to and not filed with, the SEC, will also
be incorporated by reference into this prospectus and deemed to be part of this prospectus from the date of the filing of such reports
and documents.
You
may obtain a copy of any or all of the documents referred to above which may have been or may be incorporated by reference into this
prospectus, except for exhibits to those documents (unless the exhibits are specifically incorporated by reference into those documents)
at no cost to you by contacting us at the following address and telephone number: Investor Relations, Abeona Therapeutics Inc., 6555
Carnegie Avenue, 4th Floor, Cleveland, Ohio 44103, telephone (646) 813-4701.
LEGAL
MATTERS
The
validity of the common stock offered hereby will be passed upon for us by Willkie Farr & Gallagher LLP, New York, New York. Covington
& Burling LLP, New York, New York, will act as counsel to the Agent in connection with this offering.
EXPERTS
The
financial statements of Abeona Therapeutics, Inc. as of December 31, 2023, and for the year ended December 31, 2023, incorporated by
reference in this prospectus by reference to Abeona Therapeutics, Inc.’s annual report on Form 10-K for the year ended December
31, 2023, have been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their
report. Such financial statements are incorporated by reference in reliance upon the report of such firm given their authority as experts
in accounting and auditing.
The
consolidated financial statements for the fiscal year ended December 31, 2022, incorporated by reference from the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2023, have been audited by Whitley Penn LLP, an independent registered public
accounting firm, as stated in its report filed with the Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2023, which is also incorporated herein by reference. Such financial statements have been so incorporated in reliance upon the report
of such firm given upon their authority as experts in accounting and auditing.
$75,000,000
COMMON
STOCK
PROSPECTUS
Jefferies
LLC
June ,
2024.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
We
estimate that expenses payable by us in connection with the offering described in this registration statement will be as follows:
| SEC Registration Fee | |
$ | 17,406 | |
| Legal Fees and Expenses | |
$ | 125,000 | * |
| Accounting Fees and Expenses | |
$ | 35,000 | * |
| Total | |
$ | 177,406 | * |
| * |
Estimated
as permitted under Item 511 of Regulation S-K. |
Item
15. Indemnification of Directors and Officers.
Section
145 of DGCL empowers a Delaware corporation to indemnify its officers and directors and certain other persons to the extent and under
the circumstances set forth therein.
Our
Certificate of Incorporation and Bylaws provide for indemnification of our officers and directors and certain other persons against liabilities
and expenses incurred by any of them in certain stated proceedings and under certain stated conditions.
The
above discussion of our Certificate of Incorporation, as amended, Bylaws and Section 145 of DGCL is not intended to be exhaustive and
is qualified in its entirety by such Certificate of Incorporation, Bylaws, and statute.
The
Company maintains a general liability insurance policy that covers certain liabilities of the Company’s directors and officers
arising out of claims based on acts or omissions in their capacities as directors or officers.
In
any underwriting agreement that the Company enters into in connection with the sale of common stock being registered hereby, the underwriters
will agree to indemnify, under certain conditions, the Company, its directors, its officers, and persons who control the Company within
the meaning of the Securities Act, against certain liabilities.
Item
16. Exhibits
See
Exhibit Index below, which is incorporated herein by reference.
Item
17. Undertakings.
(a)
The undersigned Registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:
(i)
To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii)
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective
amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range
may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective registration statement;
(iii)
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or
any material change to such information in the registration statement;
provided,
however, that paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in reports filed with or furnished to the Commission by Registrant pursuant to Section 13
and Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained
in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the
termination of the offering.
(4)
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i)
Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the
date the filed prospectus was deemed part of and included in the registration statement; and
(ii)
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on
Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required
by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier
of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the
offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date
an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the
registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is
part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or
modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in
any such document immediately prior to such effective date.
(5)
That, for the purpose of determining liability of the Registrant under the Securities Act of 1933 to any purchaser in the initial distribution
of the securities:
The
undersigned Registrant undertakes that in a primary offering of securities of the undersigned Registrant pursuant to this Registration
Statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold
to such purchaser by means of any of the following communications, the undersigned Registrant will be a seller to the purchaser and will
be considered to offer or sell such securities to such purchaser:
(i)
Any preliminary prospectus or prospectus of the undersigned Registrant relating to the offering required to be filed pursuant to Rule
424;
(ii)
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned Registrant or used or referred to by
the undersigned Registrant;
(iii)
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned Registrant
or its securities provided by or on behalf of the undersigned Registrant; and
(iv)
Any other communication that is an offer in the offering made by the undersigned Registrant to the purchaser.
(b)
The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing
of the Registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of
the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred
or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is
asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication
of such issue.
(e)
The undersigned Registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to
act under subsection (a) of section 310 of the Trust Indenture Act (“Act”) in accordance with the rules and regulations prescribed
by the Commission under section 305(b)(2) of the Act.
INDEX
TO EXHIBITS
| 1.1* |
|
Form
of Underwriting Agreement |
| |
|
|
| 3.1 |
|
Restated Certificate of Incorporation of Abeona Therapeutics Inc. (incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019). |
| |
|
|
| 3.2 |
|
Amended
and Restated Bylaws of Abeona Therapeutics Inc. (incorporated by reference to Exhibit 3.3 of the Company’s Form 10-K filed
on March 29, 2023). |
| |
|
|
| 3.3* |
|
Form
of Certificate of Designations, Rights and Preferences |
| |
|
|
| 4.1 |
|
Form
of Indenture (incorporated by reference to Exhibit 4.1 of the Company’s Form S-3 filed on June 12, 2024). |
| |
|
|
| 4.2 |
|
Form
of stock certificate evidencing shares of common stock, $0.01 par value per share, of the Company (incorporated by reference
to Exhibit 4.1 of the Company’s Form S-3 filed on May 14, 2015) |
| |
|
|
| 4.3* |
|
Form
of stock certificate evidencing shares of preferred stock, $0.01 par value per share, of the Company |
| |
|
|
| 4.4* |
|
Form
of Common Stock Warrant Agreement and Warrant Certificate |
| |
|
|
| 4.5* |
|
Form
of Preferred Stock Warrant Agreement and Warrant Certificate |
| |
|
|
| 4.6* |
|
Form
of Debt Securities Warrant Agreement and Warrant Certificate |
| |
|
|
| 10.1 |
|
Director
Designation Agreement dated November 15, 2007, between the Company and SCO Capital Partners LLC (incorporated by reference
to Exhibit 10.26 of the Company’s Form S-1 filed on March 11, 2008) |
| |
|
|
| 10.2 |
|
Form
of Warrant Agreement between the Company and American Stock Transfer & Trust Company (incorporated by reference to Exhibit
4.1 of the Company’s Pre-effective Amendment No. 1 to Form S-1 filed October 24, 2014) |
| |
|
|
| 10.3 |
|
Open Market Sale Agreement, dated August 17, 2018, by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 of Form 8-K filed on August 20, 2018) |
| |
|
|
| 10.4 |
|
Amendment No. 1 to Open Market Sale Agreement, dated November 19, 2021, amending the Open Market Agreement, by and between the Company and Jefferies LLC, dated August 17, 2018 (incorporated by reference to Exhibit 1.2 of Form 8-K filed on November 19, 2021) |
| |
|
|
| 5.1 |
|
Opinion of Willkie Farr & Gallagher LLP (incorporated by reference to Exhibit 5.1 of the Company’s Form S-3 filed on June 12, 2024) |
| |
|
|
| 23.1 |
|
Consent
of Deloitte & Touche LLP (incorporated by reference to Exhibit 23.1 of the Company’s Form S-3 filed on June 12, 2024) |
| |
|
|
| 23.2 |
|
Consent
of Whitley Penn LLP (incorporated by reference to Exhibit 23.2 of the Company’s Form S-3 filed on June 12, 2024) |
| |
|
|
| 23.3 |
|
Consent
of Willkie Farr & Gallagher LLP (incorporated by reference to Exhibit 23.3 of the Company’s Form S-3 filed on June 12, 2024) |
| |
|
|
| 24.1 |
|
Powers
of Attorney (included on signature page to the Company’s Form S-3 filed on June 12, 2024) |
| |
|
|
| 25.1* |
|
Form
T-1 Statement of Eligibility of Trustee Under Indenture |
| * |
To
be filed, if necessary, subsequent to the effectiveness of this Registration Statement by an amendment to this Registration Statement
or incorporated by reference pursuant to a Current Report on Form 8-K in connection with an offering of securities, as appropriate. |
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has duly caused this Amendment No. 1 to the Registration Statement
to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Morristown, in the state of New Jersey, on the
17th day of June, 2024.
| |
ABEONA
THERAPEUTICS INC. |
| |
|
|
| |
By: |
/s/
Joseph Vazzano |
| |
|
Joseph
Vazzano |
| |
|
Chief
Financial Officer |
| |
|
(Principal
Financial Officer and Principal Accounting Officer) |
POWER
OF ATTORNEY
Each
person whose signature appears below hereby appoints Vishwas Seshadri and Joseph Vazzano and each of them, severally, as his or her true
and lawful attorney or attorneys-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or
her name, place, and stead, in any and all capacities, to sign any and all amendments to this Registration Statement (including all pre-effective
and post-effective amendments and registration statements filed pursuant to Rule 462 under the Securities Act of 1933, as amended), and
to file the same with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission,
granting unto said attorney-in-fact and agent full power and authority to do and perform each act and thing requisite and necessary to
be done, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said
attorney-in-fact and agent, or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed below by the following persons
in the capacities and on the dates indicated.
| Name |
|
Title |
|
Date |
| |
|
|
|
|
/s/
Vishwas Seshadri
Vishwas
Seshadri |
|
Chief
Executive Officer and Director
(principal
executive officer) |
|
June
17, 2024 |
| |
|
|
|
|
/s/
Joseph Vazzano
Joseph
Vazzano |
|
Chief
Financial Officer
(principal
financial and accounting officer) |
|
June
17, 2024 |
| |
|
|
|
|
*
Leila
Alland |
|
Director |
|
June
17, 2024 |
| |
|
|
|
|
*
Mark
Alvino |
|
Director |
|
June
17, 2024 |
| |
|
|
|
|
*
Michael
Amoroso |
|
Director |
|
June
17, 2024 |
| |
|
|
|
|
*
Faith
Charles |
|
Director |
|
June
17, 2024 |
| |
|
|
|
|
*
Christine
Berni Silverstein |
|
Director |
|
June
17, 2024 |
| |
|
|
|
|
*
Donald
Wuchterl |
|
Director |
|
June
17, 2024 |
| *
By: |
/s/
Vishwas Seshadri |
|
| |
Vishwas
Seshardi |
|
| |
Attorney-in-fact |
|
Exhibit 107
Calculation
of Filing Fee Table
Form
S-3
(Form
Type)
Abeona
Therapeutics Inc.
(Exact
Name of Registrant as Specified in its Charter)
Newly
Registered and Carry Forward Securities
CALCULATION
OF REGISTRATION FEE
| | |
Security
Type | |
Security
Class Title | |
Fee
Calculation or Carry Forward Rule | | |
Amount
Registred | | |
Proposed
Maximum Offering Price Per Unit | | |
Maximum
Aggregate Offering Price | | |
Fee
Rate | | |
Amount
of Registration Fee | | |
Carry
Forward Form Type | | |
Carry
Forward File Number | | |
Carry
Forward Initial Effective Date | | |
Filing
Fee Previously Paid in Connection with Unsold Securities to be Carried Forward | |
| | |
Newly
Registered Securities | |
| Fees
to Be Paid | |
Equity | |
Common
Stock, $0.01 par value per share | |
| 457 | (o) | |
| (2 | )(3) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| Fees
to Be Paid | |
Equity | |
Preferred
Stock, $0.01 par value per share | |
| 457 | (o) | |
| (2 | )(3) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| Fees
to Be Paid | |
Debt | |
Debt
securities | |
| 457 | (o) | |
| (2 | )(3) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| Fees
to Be Paid | |
Equity | |
Warrants | |
| 457 | (o) | |
| (2 | )(3) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| Fees
to Be Paid | |
Unallocated
(Universal Shelf) | |
Unallocated
(Universal Shelf)(1) | |
| 457 | (o) | |
| (2 | )(3) | |
| - | | |
| 300,000,000 | | |
$ | 0.00014760 | | |
$ | 44,280 | | |
| - | | |
| - | | |
| - | | |
| - | |
| Fees
Previously Paid | |
- | |
- | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| | |
Carry
Forward Securities | |
| Carry
Forward Securities | |
Equity | |
Common
Stock, $0.01 par value per share | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-256850 | | |
| October
22, 2021 | | |
| (1 | ) |
| Carry
Forward Securities | |
Equity | |
Preferred
Stock, $0.01 par value per share | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-256850 | | |
| October
22, 2021 | | |
| (1 | ) |
| Carry
Forward Securities | |
Debt | |
Debt
securities | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-256850 | | |
| October
22, 2021 | | |
| (1 | ) |
| Carry
Forward Securities | |
Equity | |
Warrants | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-256850 | | |
| October
22, 2021 | | |
| (1 | ) |
| Carry
Forward Securities | |
Unallocated
(Universal Shelf) | |
Unallocated
(Universal Shelf)(1) | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
$ | 250,000,000 | (1)(3) | |
$ | 0.00010910 | | |
| (1 | ) | |
| S-3 | | |
| 333-256850 | | |
| October
22, 2021 | | |
$ | 11,390.04 | (1) |
| | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Carry
Forward Securities | |
Equity | |
Common
Stock, $0.01 par value per share | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-224867 | | |
| June
7, 2018 | | |
| (1 | ) |
| Carry
Forward Securities | |
Equity | |
Preferred
Stock, $0.01 par value per share | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-224867 | | |
| June
7, 2018 | | |
| (1 | ) |
| Carry
Forward Securities | |
Debt | |
Debt
securities | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-224867 | | |
| June
7, 2018 | | |
| (1 | ) |
| Carry
Forward Securities | |
Equity | |
Warrants | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
| (1 | )(3) | |
| | | |
| (1 | ) | |
| S-3 | | |
| 333-224867 | | |
| June
7, 2018 | | |
| (1 | ) |
| Carry
Forward Securities | |
Unallocated
(Universal Shelf) | |
Unallocated
(Universal Shelf)(1) | |
| 415 | (a)(6) | |
| (1 | )(2)(3) | |
| | | |
$ | 500,000,000 | (1)(3) | |
$ | 0.00012450 | | |
| (1 | ) | |
| S-3 | | |
| 333-224867 | | |
| June
7, 2018 | | |
$ | 15,484.69 | (1) |
| | |
| |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Carry
Forward Securities | |
Total
Offering Amounts | | |
$ | 300,000,000 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Carry
Forward Securities | |
Total
Fees Previously Paid | | |
$ | 17,405.27 | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Carry
Forward Securities | |
Total
Fee Offsets | |
$ | 26,874.73 | (1) | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Carry
Forward Securities | |
Net
Fee Due | | |
$ | 0.00 | (1) | |
| | | |
| | | |
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(1) The
Registrant previously registered $500,000,000 in aggregate offering price of securities pursuant to the Registration Statement on Form
S-3 (File No. 333-224867) filed on May 11, 2018, and initially declared effective on June 7, 2018, as amended from time
to time (the “First Registration Statement”), approximately $124,375,000 of which remains unsold as of the date of filing
of this registration statement (the “First Registration Statement Unsold Securities”). The Registrant also previously registered
$250,000,000 in aggregate offering price of securities pursuant to the Registration Statement on Form S-3 (File No. 333-256850) filed
on June 7, 2021, and declared effective on October 22, 2021 (the “Second Registration Statement” and, together with the First
Registration Statement, the “Prior Registration Statements”), approximately $104,400,000 of which remains unsold as of the
date of filing of this registration statement (the “Second Registration Statement Unsold Securities” and, together with the
First Registration Statement Unsold Securities, the “Unsold Securities”). The Registrant expects to carry forward to this
registration statement the Unsold Securities pursuant to Rule 415(a)(6) under the Securities Act of 1933, as amended. The Registrant
previously paid a registration fee of $62,250 in connection with the filing of the First Registration Statement. The Registrant used
$27,275 of the unused filing fees from $250,000,000 of the unsold securities from the First Registration Statement to offset the full
registration fee payable in connection with the Second Registration Statement. The $26,874.73 previously paid filing fees relating to
the Unsold Securities under the Prior Registration Statements will continue to be applied to such Unsold Securities registered on this
registration statement. For reasons stated above, the net registration fee paid in connection with the Unsold Securities is $17,405.27.
(2) Pursuant to Rule 416 of the Securities Act, this
Registration Statement also includes additional shares of common stock issuable upon stock splits, stock dividends or similar transactions.
These offered securities may be sold separately, together or as units with other offered securities. An unspecified number of securities
or aggregate principal amount, as applicable, is being registered as may from time to time be offered at unspecified prices.
(3) Pursuant to Rule 457(o) under the Securities Act,
which permits the registration fee to be calculated on the basis of the maximum offering price of all the securities listed, the table
does not specify by each class information as to the amount to be registered, proposed maximum offering price per unit or proposed maximum
aggregate offering price. The aggregate public offering price of securities sold by the Registrant (including newly listed securities
and carry-forward securities) will not exceed $300,000,000.
(4) To the extent that, after the filing date hereof
and prior to the effectiveness of this registration statement, the Registrant sells any Unsold Securities pursuant to the Prior Registration
Statements, the Registrant will identify in a pre-effective amendment to this registration statement the updated amount of Unsold Securities
from the Prior Registration Statements to be included in this registration statement pursuant to Rule 415(a)(6). Pursuant to Rule 415(a)(6),
the offering of the Unsold Securities under the Prior Registration Statements will be deemed terminated as of the date of effectiveness
of this registration statement.
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